Cognitive impairment after acute ischemic stroke
Conditions
Interventions
Extract of Ginkgo Biloba Leaves Tablets plus standard of care (SoC) Group:Extract of Ginkgo Biloba Leaves Tablets
Standard of care (SoC) Group:Individualized therapy in accordance with treatment guideline from the Chinese Stroke Association
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male and female participants aged >= 55 years who gave their informed consent. 2. Non-disabling overt acute ischemic stroke (NIHSS <= 5, mRS <= 2 at the day of screening) confirmed by magnetic resonance imaging, and at least 7 but no longer than 14 days before baseline. 3. Cognitive impairment (MoCA total score (corrected) < 23 for participants with up to 12 years of education, or MoCA total score < 22 if more than 12 years of education). 4. Sufficient Chinese language skills to understand and respond to all interview questions, complete questionnaires, and undergo neuropsychological testing.
Exclusion criteria
Exclusion criteria: 1.Participation in another experimental drug trial at the same time or within the past 4 weeks before enrollment. 2.Aphasia, dysarthria, apraxia or paresis of the dominant upper extremity, severe and insufficiently corrected loss of vision or hearing, severe language difficulties or any other disability that may prevent the participant from cooperating adequately in the trial or that may interfere with neuropsychological test performance. 3.Pre-stroke cognitive impairment (16-item Informant Questionnaire on Cognitive Decline (IQCODE) score >= 3.3), preexisting major neurocognitive disorder (e. g., dementia due to Alzheimer’s disease, vascular dementia, dementia with Lewy bodies, frontotemporal dementia). 4.Cardiogenic ischemic stroke, atrial fibrillation, or any other conditions that require the intake of anticoagulants. 5.Conditions that require the administration of thrombolytics at day of Screening or Visit 1; 6.Index acute ischemic stroke with hemorrhagic transformation. 7.Intake of traditional Chinese medicines. 8.Major neurological disorder, including intracranial hemorrhage, delirium, Parkinson’s disease, brain tumor, alcohol-associated brain damage, infectious disease of the central nervous system (CNS), epilepsy, recent brain trauma, subdural hematoma, HIV-associated cognitive disorder, Huntington’s disease, Pick’s disease, Wilson’s disease, normal pressure hydrocephalus, hydrocephalus, progressive supra-nuclear palsy, Creutzfeldt-Jakob disease, etc. 9.Major depression or generalized anxiety disorder; 10.Active malignant disease; 11.Alcohol addiction or substance abuse; 12.Known hypersensitivity to Ginkgo biloba, Ginkgo biloba extract or any ingredient of the drug under trial. 13.Any circumstances that prevent the participant to be followed up at the scheduled intervals. Hospitalization of the participant for long-term treatment or nursing home placement for bedside care (assisted living facility residence or stay in a rehabilitation facility is acceptable if the participant is not bedridden and does not need general bedside nursing, and if an informant is available who sees the participant on a regular basis and accompanies him/her to the trial visits). 14.Severe comorbidity with life expectancy < 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6) in the following test scores:MoCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6) in the following test scores:ADCS-CGIC;Change from baseline to Week 26 (Visit 4) and Week 52 (Visit 6) in the following test scores: TMT-A, TMT-B , SDMT, VFT;Frequency and nature of AEs, ADRs, and SAEs documented by the Investigators after 4 weeks, 12 weeks, 26 weeks, 38 weeks and 52 weeks.;Any new stroke events (ischemic stroke or hemorrhagic stroke) at Week 4, Week 12, Week 26, Week 38 and Week 52.;Change from Baseline to Week 4 (Visit 1), Week 26 (Visit 4) and Week 52 (Visit 6) in neurological impairment (NIHSS and mRS).; | — |
Countries
China
Contacts
Public ContactYongjun.Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed